Atrial FibrillationNCT01991951
Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation
A study testing warfarin in people with Atrial Fibrillation, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
We hypothesized that in patients with low CHADS-VASc score (2 or < 2), there is no difference in thromboembolic or bleeding events between patients with short term warfarin therapy (2 weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after procedure). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with paroxysmal atrial fibrillation who underwent radiofrequency catheter ablation
- Patients with CHADS-VASc score 2 or less than 2
Who cannot join
- Patients who do not consent to the study
- Permanent or persistent atrial fibrillation
- Patients who have underwent prior catheter ablation for atrial fibrillation
- CHADS-VASc score more than 2
- History of stroke
- LVEF <40%
- Significant liver or kidney dysfunction
- History of major bleeding during warfarin therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, 136-705
Jaemin Shim, MD, 82-10-6776-1195, jshim@kumc.or.kr
About this study
Official title: Prospective Randomized Study of Incidence of Thromboembolic and Bleeding Events According to the Period of Warfarin Use Before and After Catheter Ablation of Paroxysmal Atrial Fibrillation in Low Risk Patients
We hypothesized that in patients with low CHADS-VASc score (2 or < 2), there is no difference in thromboembolic or bleeding events between patients with short term warfarin therapy (2 weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after procedure).
- Conditions
- Atrial Fibrillation
- Being tested
- warfarin
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarinDrug
| Study group | Role | What they receive |
|---|---|---|
| Short term warfarin group | Experimental | taking warfarin for only 2 weeks after catheter ablation of atrial fibrillation Receives: Drug: warfarin |
| Conventional therapy arm | Active comparator | conventional warfarin therapy of 3 weeks before and 8 weeks after catheter ablation of AF Receives: Drug: warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of thromboembolic and bleeding events during 2 months
Measured: 2 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2015 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Hoon Kim, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991951
- Sponsor's protocol ID
- KUMCEP01
- Status last verified
- Nov 2013
- First submitted
- 18 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Incidence of Thromboembolic and Bleeding Events According to the Period of Warfarin Use Before and After Catheter Ablation of Paroxysmal Atrial Fibrillation in Low Risk Patients
- ClinicalTrials.gov ID
- NCT01991951
- Acronym / sponsor ID
- KUMCEP01
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesized that in patients with low CHADS-VASc score (2 or < 2), there is no difference in thromboembolic or bleeding events between patients with short term warfarin therapy (2 weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after procedure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short term warfarin group | Experimental | Drug: warfarintaking warfarin for only 2 weeks after catheter ablation of atrial fibrillation |
| Conventional therapy arm | Active comparator | Drug: warfarinconventional warfarin therapy of 3 weeks before and 8 weeks after catheter ablation of AF |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with paroxysmal atrial fibrillation who underwent radiofrequency catheter ablation
- Patients with CHADS-VASc score 2 or less than 2
Key exclusion criteria (8 listed)
- Patients who do not consent to the study
- Permanent or persistent atrial fibrillation
- Patients who have underwent prior catheter ablation for atrial fibrillation
- CHADS-VASc score more than 2
- History of stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| warfarin | Drug | Conventional therapy arm, Short term warfarin group |
Primary outcome
Incidence of thromboembolic and bleeding events during 2 months
Time frame: 2 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warfarin in people with Atrial Fibrillation, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaemin Shim, MD (82-10-6776-1195, jshim@kumc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of thromboembolic and bleeding events during 2 months (time frame: 2 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.